Training with dual tasks in Parkinson's disease
| ISRCTN | ISRCTN49538525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49538525 |
| Secondary identifying numbers | 76-1-6/2019 |
- Submission date
- 08/09/2021
- Registration date
- 10/09/2021
- Last edited
- 09/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Parkinson's disease (PD) is a condition in which parts of the brain become progressively damaged over many years.
Dual-task performance training (performing two tasks at the same time) has gained great interest in the treatment of patients with Parkinson’s disease. Movement (motor) function has received the most attention and walking can be improved significantly, but the present study includes an assessment of cognitive function in addition to motor parameters.
This study included assessments of short-term and long-term improvement with results on the duration of the shortest effective training protocol and on the maintenance of improvement.
Who can participate?
Patients with PD and healthy age-matched controls
What does the study involve?
Five dual-task tests (including primary cognitive and secondary motor tasks), were performed on five consecutive days and were repeated after 6 and 12 months.
What are the possible benefits and risks of participating?
The benefit for the participants involved in the study is the improvement in their attention and executive function after training with dual-task performances. The risk was the sliding glass plate, therefore every subject wore socks with rubberized soles.
Where is the study run from?
Institute of Neurorehabilitation (Hungary)
When is the study starting and how long is it expected to run for?
December 2018 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Judit Málly MD, PhD, dr.habil.mallyjudit@gmail.com
Contact information
Scientific
Institute of Neurorehabilitation
Major-köz 3.
Sopron
9400
Hungary
 ORCID ID |
0000-0003-4646-7952 |
|---|---|
| Phone | +36 203920031 |
| dr.habil.mallyjudit@gmail.com |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 40388 PIS.pdf |
| Scientific title | Cognitive improvement after training with dual-tasks in Parkinson's disease. Follow up study. |
| Study objectives | Dual-task training on walking tests can improve the decline of gait parameters, although training on cognitive abilities in PD has received little study. In addition, it is not clear at what age or stage of PD it would be most appropriate and successful to employ dual-task performance testing for cognitive rehabilitation. The present study was therefore designed to examine the effect of short duration training with different dual-task tests on performance and to examine the duration of any improvement for up to 12 months. |
| Ethics approval(s) | Approved 25/05/2019, The Regional Ethics Committee of the Petz Aladár County Hospital in Győr (Győr, Vasvári Pál u. 2-4, 9023, Hungary; +3696/507-900; oharics@petz.gyor.hu), ref: 76-1-6/2019 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | The subjects were divided into two groups according to age (under and over 65 years). The control group had no chronic disease, except for well-controlled hypertension. Dual-task performances are examined using Dividat Senso equipment (HUR, Finland), with subjects standing on a glass platform overlying sensors. A cognitive task is combined with a motor activity task in each test period, with subjects asked to focus on a game presented on a visual monitor. For the motor task, patients are asked to detect an object appearing at one edge (top, bottom, right or left) of the screen and are required to react using leg movements. Five dual-task tests will be applied. For cognitive testing, a second (‘Bird’) task is used in which a bird had to be selected from different colored figures. In a ‘Simple’ task, red spots are shown at different positions. In the game ‘Divided’, red spots are linked to high and low sounds, which require patient movement. In the game ‘Habitat’ four different animals has to be allocated to their appropriate living area. Dual-task interactions are quantified by the average reaction times. In the game of ‘Target’, black bullets move around the monitor, with different speeds, the subject being asked to calculate the speed of the bullets. Correct and incorrect responses are recorded. The following traditional tests are also applied; the Mini Mental Rating Scale. the Ziehen Ranschburg Word Pair Test, Trail Making Test, Clock Drawing Test, and the Hamilton Depression Scale Tests. For the detection and quantitation of Parkinsonian symptoms the Hoehn-Yahr Stages are used together with the Unified Parkinson Disability Rating Scale. Walking ability is measured as distance walked in 6 mins (in m), and time taken to walk 10m (in sec). The walking tests are performed on the first and fifth days of training. |
| Intervention type | Other |
| Primary outcome measure | Dual-task test performances are measured using Dividat Senso equipment for one and a half minutes each day and repeated each day for five consecutive days. This is repeated at 6 and 12 months. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2018 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Number of Parkinsonian participants: 46 Number of age matched healthy controls: 47 |
| Total final enrolment | 93 |
| Key inclusion criteria | 1. Patients with PD and age-matched healthy controls 2. PD patients: 2.1 The presence of Parkinson’s disease responding well to levodopa 2.2 No evidence of dementia or any other chronic disease 2.3 Patients with PD in Hoehn-Yahr stages I and II (H-Y I-II) |
| Key exclusion criteria | No evidence of dementia or any other chronic disease |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/11/2019 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Sopron
9400
Hungary
Sponsor information
Hospital/treatment centre
Major-köz 3.
Sopron
9400
Hungary
| Phone | +36 203920031 |
|---|---|
| neurorehabilitaciosopron@gmail.com | |
| Website | http://www.neurorehab.hu |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 01/02/2022: Submitting manuscript to Brain Research. Previous publication and dissemination plan: Submitting manuscript to Clinical Rehabilitation. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. dr.habil.mallyjudit@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/09/2021 | No | Yes | ||
| Preprint results | 04/01/2022 | 16/06/2022 | No | No | |
| Preprint results | 29/04/2022 | 16/06/2022 | No | No | |
| Protocol file | 09/08/2022 | No | No |
Additional files
Editorial Notes
09/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
16/06/2022: Preprint references added.
01/02/2022: The following changes have been made:
1. The intention to publish date has been changed from 31/12/2021 to 31/12/2022.
2. The publication and dissemination plan has been updated.
10/09/2021: Trial's existence confirmed by Regional Ethics Committee of the Petz Aladár County Hospital in Győr.
